CODAR D

Dosage form: liquid
Ingredients: Codeine Phosphate 8mg in 5mL, Pseudoephedrine Hydrochloride 30mg in 5mL
Labeler: Respa Pharmaceuticals
NDC Code: 60575-515

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Codar D

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

Codeine Phosphate* 8 mg
*(Warning:  May be habit-forming)
Pseudoephedrine Hydrochloride 30 mg

PurposeCough Suppressant
Nasal Decongestant

Usestemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings Do not exceed recommended dosage.

Do not use this product
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • chronic pulmonary disease or shortness of breath or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • difficulty in urination due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

When using this product
  • may cause or aggravate constipation

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  These could be signs of a serious condition.
  • new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison control Center right away.

Directions Do not exceed recommended dosage.
Adults and Children
12 years of age and
over:
2 teaspoonfuls (10 mL)
every 4-6 hours, not to
exceed 8 teaspoonfuls
in a 24 hour period.
Children 6 to under
12 years of age:
1 teaspoonful (5 mL)
every 4-6 hours, not to
exceed 4 teaspoonfuls
in a 24 hour period.
Children under 6
years of age:
Not recommended
for use.

Other informationStore at 15°- 30°C (59°- 86°F)

Inactive ingredientsBerry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

Questions? Comments?Call (630) 543-3333

Rx Only

CV

Manufactured for:
RESPA®
PHARMACEUTICALS, INC.
Addison, IL  60101

Product PackagingThe packaging below represents the labeling currently used:

Principal display panel and side pane for 473 mL label:

NDC 60575-515-16
_____________________________________
Codar® D

Cough Suppressant / Nasal Decongestant
_____________________________________


CV

Each 5 mL (one teaspoonful) for oral
administration contains:

Codeine Phosphate*..............................8 mg
Pseudoephedrine HCl...........................30 mg

Berry Flavor

Rx Only

RESPA®
PHARMACEUTICALS, INC.
Addison, IL  60101

16 fl oz. (473 mL)


SEE ATTACHED PRODUCT INSERT FOR
COMPLETE DOSING INFORMATION.

Tamper evident by foil seal under cap.  Do
not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container
as defined in the USP/NF with a child-resistant
closure.

Store at controlled room temperature, 15°- 30°C
(59°- 86°F).

KEEP THIS AND ALL MEDICATIONS OUT
OF THE REACH OF CHILDREN.


Manufactured for:
Respa Pharmaceuticals
Addison, IL  60101

Rx Only

Rev. 06/11




CODAR   D
codeine phosphate, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60575-515
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (Codeine) Codeine Phosphate8 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:60575-515-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/13/2011
Labeler - Respa Pharmaceuticals (883901019)

Revised: 07/2011
 
Respa Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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